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21:03 EDT 26th October 2016 | BioPortfolio

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Vantrela ER hydrocodone bitartrate regulatory update

Teva's pain treatment recommended for FDA approval

Teva Pharmaceutical Industries' twice-daily tablet Vantrela ER, or hydrocodone bitartrate, has been endorsed for approval by  -More- 

Teva Gains Recommendation for Approval from FDA Advisory Committees for Vantrela ER (hydrocodone bitartrate) Extended-Release Tablets

JERUSALEM--(BUSINESS WIRE)--Jun. 7, 2016-- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety ...

FDA panels recommend Teva's Vantrela ER

FDA's Anesthetic and Analgesic Drug Products committee and Drug Safety and Risk Management advisory committee voted 14-3 to recommend approval of Vantrela ER hydrocodone bitartrate (CEP-33237) from Te...

ED Hydrocodone/Acetaminophen Prescriptions in the VA

How have prescribing patterns for hydrocodone/acetaminophen among veterans changed in recent years? Western Journal of Emergency Medicine: Integrating Emergency Care with Population Health

Report: Prescriptions for Hydrocodone-containing Combination Drugs Drop

The switch of hydrocodone-containing combination drugs from Schedule III to the more restrictive Schedule II in October 2014 significantly reduced the number of prescriptions filled for these drugs, a...

Abuse-Deterrent Hydrocodone ER Safe, Effective in Back Pain

An extension study shows that patients receiving an investigational abuse-deterrent hydrocodone (Vantrela ER) maintained pain relief for 6 months and that the drug was still safe. Medscape Medical N...

Collegium unveils positive topline results for Hydrocodone DETERx clinical study

Collegium Pharmaceutical has unveiled positive topline results from a clinical study evaluating Hydrocodone DETERx as a second product candidate using its proprietary DETERx drug delivery technology p...

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Hydrocodone Bitartrate ER (Hysingla(®) ER): A Review in Chronic Pain.

Hydrocodone bitartrate extended-release (Hysingla(®) ER; referred to hereafter as hydrocodone ER) was the first single-entity hydrocodone formulation recognized by the US FDA as having abuse-deterren...

Oral Abuse Potential, Pharmacokinetics, and Safety of Once-Daily, Single-Entity, Extended-Release Hydrocodone (HYD) in Recreational Opioid Users.

 A once-daily, extended-release hydrocodone bitartrate tablet with abuse-deterrent properties (Hysingla ER [HYD]) is available for the treatment of chronic pain in appropriate patients. This study e...

Pharmacokinetic Profile and Sustained 24-hour Analgesia of a Once-daily Hydrocodone Bitartrate Extended-release Tablet with Abuse-deterrent Properties.

The purpose of this study was to evaluate the pharmacokinetics (PK) and 24-hour analgesic effectiveness of once-daily, single-entity, extended-release hydrocodone (HYD) with abuse-deterrent properties...

Opioid Treatment Patterns Following Prescription of Immediate-Release Hydrocodone.

Immediate-release (IR) hydrocodone is the most widely prescribed opioid in the United States; however, little is known about the utilization patterns and duration of opioid use among patients prescrib...

Physicians' intention to prescribe hydrocodone combination products after rescheduling: A theory of reasoned action approach.

The U.S. Drug Enforcement Administration (DEA) rescheduled hydrocodone combination products (HCPs) in an attempt to mitigate the prescription opioid epidemic. Many in the medical and pharmacy communit...

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